MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SUBCUTANEOUS FASCIA CLOSURE DEVICE

Model Number	26173AM
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have not yet received the item for evaluation.
Event or Problem Description
Allegedly, at the end of a laparoscopic vertical sleeve gastrectomy, possible liver biopsy, laparoscopic/possible open cholecystectomy procedure, the jaw of the fascia closure device broke off into the patient.The broken piece was retrieved in approximately 20 minutes.Hospital reported the patient is doing fine.
Additional Manufacturer Narrative
We evaluated the instrument.The fixed jaw is missing, the solder on the jaws pin is broken, the shaft is bent, and the proximal end epoxy seal is broken.Breakage is most likely due to stress overload.

• Brand Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• Common Device Name: SUBCUTANEOUS FASCIA CLOSURE DEVICE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• MDR Report Key: 7115817
• Report Number: 9610617-2017-00099
• Device Sequence Number: 13742359
• Product Code: GCJ
• UDI-Device Identifier: 04048551097755
• UDI-Public: 4048551097755
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K942612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 26173AM
• Device Catalogue Number: 26173AM
• Device Lot Number: RU04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 133